Merits Healthcare Industries. (Suzhou) Co., Ltd.
Registered establishment in Jiangsu, China. 31 device types, 1 clearance.
Merits Healthcare Industries. (Suzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Crutch, Bed, Manual and 29 other device types. Its earliest product listing with the FDA dates from 2008.
31device types registered with the FDA
1510(k) clearance
Registration
| Registered name | MERITS HEALTHCARE INDUSTRIES. (SUZHOU) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 9618009 |
| FEI number | 3003327839 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 美利驰医疗器械（苏州）有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Jiangsu |
|---|---|
| Province | Jiangsu |
| Address | NO. 29 FUZHOU ROAD |
| Postal code | 215411 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Wheelchair | Class 1 | manual wheel chair accessories | 2010 | 80 |
| Adaptor, Hygiene | Class 1 | Foot Stool, Bath Bench, Raised Toilet Seat, Grab BAR, Shower Spray, Toilet Safety Frame and 2 more | 2011 | 193 |
| Armboard, Wheelchair | Class 1 | Armboard, Wheelchair | 2012 | 14 |
| Armrest, Wheelchair | Class 1 | Armrest, Wheelchair | 2012 | 29 |
| Attachment, Commode, Wheelchair | Class 1 | C317, C312, C313, C311, C316, D101 and 4 more | 2011 | 70 |
| Bariatric Bed | Class 2 | 3999AM84 | 2016 | 10 |
| Bed, Ac-Powered Adjustable Hospital | Class 2 | B311, B3112, B211, B320, B310, B330 and 1 more | 2011 | 95 |
| Bed, Manual | Class 1 | R211, R2021, B010, R210 | 2010 | 122 |
| Belt, Wheelchair | Class 1 | Belt, Wheelchair | 2012 | 24 |
| Board, Lap, Wheelchair | Class 1 | Board, LAP, Wheelchair | 2012 | 14 |
| Board, Scooter, Prone | Class 1 | Board, Scooter, Prone | 2012 | 8 |
| Brake, Extension, Wheelchair | Class 1 | Brake, Extension, Wheelchair | 2012 | 19 |
| Chair And Table, Medical | Class 1 | Over BED Table | 2011 | 94 |
| Chair, Adjustable, Mechanical | Class 1 | Chair, Adjustable, Mechanical | 2012 | 46 |
| Chair, With Casters | Class 1 | Chair, With Casters | 2012 | 85 |
| Climber, Curb, Wheelchair | Class 1 | Climber, Curb, Wheelchair | 2012 | 13 |
| Components, Wheelchair | Class 1 | Manual Wheelchair Components | 2011 | 54 |
| Crutch | Class 1 | Forearm Crutch, Underarm Crutch, Crutch | 2011 | 112 |
| Cuff, Pusher, Wheelchair | Class 1 | Cuff, Pusher, Wheelchair | 2012 | 11 |
| Cushion, Wheelchair | Class 1 | Cushion | 2011 | 53 |
| Device, Anti-Tip, Wheelchair | Class 1 | Device, Anti-TIP, Wheelchair | 2012 | 22 |
| Exerciser, Non-Measuring | Class 1 | Pedal Exerciser | 2011 | 82 |
| Handrim, Wheelchair | Class 1 | Handrim, Wheelchair | 2012 | 12 |
| Hill Holder, Wheelchair | Class 1 | Hillholder, Wheelchair | 2012 | 9 |
| Holder, Crutch And Cane, Wheelchair | Class 1 | Holder, Crutch AND Cane, Wheelchair | 2012 | 22 |
| Restraint, Wheelchair, Non-Protective | Class 1 | Restraint, Wheelchair, NON-Protective | 2012 | 15 |
| Stand, Infusion | Class 1 | Stand, Infusion | 2011 | 75 |
| Support, Head And Trunk, Wheelchair | Class 1 | Support, Head AND Trunk, Wheelchair | 2012 | 10 |
| Vehicle, Motorized 3-Wheeled | Class 2 | S730, S731, S237, S741, S740, S247 | 2012 | 41 |
| Wheelchair, Mechanical | Class 1 | L819, N472, N424, N2469, N700, N473 and 9 more | 2008 | 46 |
| Wheelchair, Powered | Class 2 | P322A, P322B, Merits Model P322FWD Powered Wheelchair, P322, P181, P183 and 5 more | 2012 | 62 |
Clearances
1 clearance names Merits Healthcare Industries. (Suzhou) Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K170517 | 2017-11-16 | IOR | Traditional | This company |
| K013788 | 2001-12-11 | INI | Special | Merits Health Products, Inc. |
| K011707 | 2001-08-03 | INI | Special | Merits Medical Industries Co., Ltd. |
| K933662 | 1994-03-30 | ITI | Traditional | Merits Health Products, Inc. |
| K933406 | 1993-09-30 | IOR | Traditional | Merits Health Products, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Wheelchairs, Power wheels, Electric scooters, Patient aids |
|---|---|
| Certifications | ISO 9001, ISO 13485, ISO 14001 |
| Export markets | Worldwide |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Jiangsu Yuyue Medical Equipment & Supply Company Limited | 17 |
| Suzhou Armocon Technology Co., Ltd. | 5 |
| Jiangsu Betterlife Medical Co., Ltd. | 4 |
| Viant Medical Suzhou EPZ Co., Ltd. | 3 |
| Kunshan Radiant Innovation Co., Ltd. | 2 |
| Jiangsu Jsongmed Medical Material Co., Ltd. | 2 |
| Jiangsu Dongbao Optical Co., Ltd. | 2 |
| Dynamic Connect (Suzhou) Hi-Tech Electronics Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.